More about this trial

then 6 weeks of radiotherapy with temozolomide (this is called chemoradiotherapy)

then temozolomide alone for up to 6 months (this is the adjuvant treatment)

But glioblastomas can come back or continue to grow despite the usual treatment. In this trial, doctors want to find out whether ipilimumab can help to stop glioblastomas from coming back.

Ipilimumab (also called by its brand name Yervoy) is a type of targeted drug called a monoclonal antibody. It works by stimulating certain immune cells called T-cells to find and attack the cancer. Ipilimumab is already a possible treatment for people with advanced melanoma.

Everyone taking part in this trial has surgery and 6 weeks of chemoradiotherapy. They then have one of the following adjuvant treatments:

temozolomide (the usual treatment)

temozolomide and ipilimumab

The main aim of this trial is to find out whether adding ipilimumab to the usual treatment helps people with glioblastoma.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply:

you have a newly diagnosed glioblastoma

you had brain surgery and doctors removed at least a fifth of the tumour (your doctor can tell you more about this)

you started radiotherapy within 49 days (about 1 and 1/2 months) after surgery

have completed 6 weeks of radiotherapy and temozolomide (chemoradiotherapy)

you have had another active cancer apart from non melanoma skin cancer or an early cancer (carcinoma in situ) of the cervix that has been successfully treated

Medical conditions

You cannot join this trial if any of these apply. You:

have an autoimmune disease that doctors think could affect you taking part in this trial

have lung problems such as scarring of the lungs (fibrosis)

take, or have taken drugs that damp down your immune system unless it was a cream, inhaler or a very small dose

have problems with your digestive system that doctors think could affect you taking part in this trial

had a severe infection in the past month

are taking part in another clinical trial or have taken part in a trial in the past 4 weeks that looked at a new treatment (interventional trial)

have HIV

have hepatitis B or hepatitis C

have any other serious condition or mental health problem that the trial team think could affect you taking part

Other

You cannot join this trial if any of these apply. You:

are pregnant or breastfeeding

are sensitive to the drugs used in this trial or any other similar drug

Trial design

This is a phase 2 trial. Researchers hope that around 120 people from the UK will agree to take part.

Everyone has surgery to remove all or part of the tumour. And 6 weeks of radiotherapy with temozolomide (chemoradiotherapy). This is the same as the usual treatment. Your doctor can tell you more about this.

You start this trial after finishing chemoradiotherapy.

This is a randomised trial. The people taking part are put into 1 of the following groups at random:

temozolomide and ipilimumab (arm A)

temozolomide (arm B)

Neither you nor your doctor are able to decide which group you are in. You are 2 times more likely to have temozolomide and ipilimumab than temozolomide alone.

You have up to 6 treatment cycles of temozolomide. Each cycle lasts 28 days. You have each cycle in the following way. You:

take temozolomide tablets every day for 5 days

then have a break of 23 days

You then start the next cycle of treatment.

Diary card

The trial team will ask you to complete a diary card. You have a new diary card for each temozolomide treatment cycle. You fill it in every day you take temozolomide and each time you take other drugs such as steroids.

You return the diary card to the trial team when you finish each treatment cycle.

Blood tests

You have some extra blood tests as part of this trial. You have them before the start of treatment and at set times during the trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination

blood tests

urine test (for pregnancy)

During treatment, you see the trial team every 4 weeks if you join the temozolomide group (arm B). You see the trial team more regularly if you join the temozolomide and ipilimumab group (arm A).

You have blood tests and a physical examination each time you see the trial team. You may also have a pregnancy test if there is any possibility that you could become pregnant.

You have an MRI scan every 3 months during treatment. This continues for up to 6 months.

When you finish treatment, you see the trial team after 6 weeks. You then see them every month.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment.

Ipilimumab affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.

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